NCT02072967已完成不适用
Observational Program for Evaluation of Ribomustin and Rituximab Combined Therapy With Following Rituximab Maintenance of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 35
- 主要终点
- Overall response rate
研究概览
简要总结
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
- •Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee
- •Eastern Cooperative Oncology Group (ECOG) status <
- •Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment
- •Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy
排除标准
- •Indolent Non-Hodgkin's Lymphoma transformation
- •Lymphoma with central nervous system (CNS) involvement
- •Presence of second malignant tumor.
- •Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
- •Contraindications for Ribomustin usage in accordance with product label
- •Contradictions for rituximab usage in accordance with product label
结局指标
主要结局
Overall response rate
时间窗: 90 days post-treatment
次要结局
- Adverse drug reactions(up to 1 year)
研究者
研究点 (35)
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